Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

Postoperative Pain Clinical Trial

Official title:

Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138901
• Other study ID #: HS-2019-01
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: June 7, 2020

Study information

• Verified date: August 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.

Description:

Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 7, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia

• American Society of Anesthesiologists (ASA) physical classification I-III

• Consent to IV-patient controlled analgesia use

• Willingness and ability to sign an informed consent document

Exclusion Criteria:

• Do not understand our study

• Allergies to anesthetic or analgesic medications

• Wound infiltration analgesia for postoperative pain control

• Infection or anatomic abnormality at the needle insertion site

• Pregnancy/Breast feeder

• Medical or psychological disease that can affect the treatment response

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Ultrasound guided subcostal transversus abdominis plane block (TAPB)
At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.

Drug:
• Ropivacaine 0.75% Injectable Solution
0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Device:
• 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fentanyl consumption during 24 hours	postoperative cumulative fentanyl consumption (mcg)	postoperative 24 hours
Secondary	Total fentanyl consumption	postoperative cumulative fentanyl consumption (mcg)	postoperative 6, 12, 48 hours
Secondary	Postoperative pain score	11-pointed NRS pain score at resting/coughing NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"	postoperative 6, 12, 24, 48 hours
Secondary	occurrence of opioid-related side effects	Incidence of postoperative nausea and vomiting, dizziness, sedation, respiratory depression (%)	postoperative 6, 12, 24, 48 hours
Secondary	Rescue nonopioid(ketorolac, nefopam) analgesic requirement	Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement	postoperative 6, 12, 24, 48 hours